Contamine Sur Arve

This research aims to improve pregnancy success rates in women undergoing frozen embryo transfers FET after in vitro fertilization IVF. It evaluates whether placing a blank culture medium into the uterus a few days before the embryo transfer can enhance immune tolerance and support embryo implantation. The study compares this approach to a sham transfer procedure without the culture medium, focusing on women who have experienced previous embryo transfer failures. Participants are randomly assigned to one of two groups the experimental group receives a small amount of warmed embryo culture medium injected into the uterine cavity two to three days before the frozen embryo transfer, while the control group undergoes a sham transfer with an empty catheter during the same timeframe. The study is single-blind and involves multiple centers. During the trial, researchers will monitor pregnancy outcomes, including early pregnancy occurrence, biochemical and clinical pregnancy rates at various time points, early miscarriage rates, and live birth rates. They will also assess cost-effectiveness between the two care strategies. Participant involvement includes consent, membership in a health insurance plan, and follow-up evaluations up to and beyond the pregnancy period, with the primary outcome measured at 12 weeks of amenorrhea.

This research aims to describe how patients aged 18 years or older with moderate to severe atopic dermatitis AD are managed with systemic therapy. It focuses on patients eligible for or currently receiving systemic treatments, following their care under real-world conditions. The study involves French dermatologists experienced in AD management, whether practicing in hospitals or private offices. Treatment decisions are made independently by the physicians and not influenced by the study enrollment. Participants will receive systemic treatments for AD prescribed by their doctors as part of routine care, with no investigational drugs involved. Information will be collected during regular visits according to usual clinical practice. The study will follow patients for one year, tracking their treatments and management without altering standard care. During the year, patients will be assessed at baseline, 6 months, and 12 months. Researchers will collect data on previous and current treatments, treatment adherence, changes in disease severity, itch, sleep disturbance, skin pain, quality of life, psychological health, work absences, and hospitalizations related to AD. This comprehensive follow-up aims to better understand how systemic therapies are used and their impact on patients in everyday clinical settings.

Bronchiectasis is a chronic lung disease involving permanent widening of parts of the airways, leading to mucus buildup, infections, and ongoing inflammation. Researchers are evaluating whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups compared to enhanced standard care in patients with non-cystic fibrosis bronchiectasis. This study focuses on long-term effects over about two years. Participants will be randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device daily at home along with remote physiotherapy and standard care. The SIMEOX device delivers short pulses of negative air pressure through a mouthpiece to help loosen and move mucus from the lungs. Remote physiotherapy sessions occur once a month for the first three months and then every three months thereafter. During the study, participants will be monitored for changes in quality of life using questionnaires at 6, 12, and 24 months, and the number of lung exacerbations over about 24 months will be recorded. Lung function tests spirometry will also be conducted periodically. Researchers will track treatment adherence, hospitalizations, and any adverse events. The total study duration per participant is around two years, with regular assessments to evaluate the impact of the SIMEOX device combined with physiotherapy.

Researchers are conducting a long-term observational study to understand how dupilumab is used and its effects in patients with Chronic Obstructive Pulmonary Disease COPD who are treated as part of routine care. This study will follow about 350 to 500 participants in multiple sites across France over 36 months, collecting detailed information on patient characteristics, safety, and patient-reported outcomes. The goal is to describe various aspects of COPD and treatment history to better characterize this patient group. Participants in this study are those newly starting dupilumab treatment for COPD, as prescribed by their doctors in line with approved guidelines. The study does not involve any additional treatment but observes the use of dupilumab over time. No placebo or comparator group is included. Data will be collected retrospectively and prospectively, covering medical history before dupilumab initiation and ongoing treatment effects during the 36-month follow-up. Throughout the study, researchers will gather detailed data on demographics, disease characteristics, lung function, exacerbations, comorbidities, and patient-reported assessments such as quality of life and symptom scores. Safety outcomes, including adverse events and reasons for stopping treatment, will be monitored. The study duration for each participant is about 36 months, allowing long-term observation of treatment and disease progression in real-world conditions.

This research investigates GLSI-100 immunotherapy in people with HER2neu positive breast cancer who are at high risk for their cancer returning. It focuses on participants who have completed both neoadjuvant and postoperative adjuvant standard treatments. The study is Phase 3, randomized, double-blinded, and placebo-controlled, involving subjects who are HLA-A*02 positive as well as an open-label group of non-HLA-A*02 positive subjects. The goal is to evaluate the treatments impact on invasive breast cancer-free survival over a median follow-up of 4 years. Participants receive 6 primary immunization injections of GLSI-100 or placebo intradermally once a month for the first 6 months, followed by 5 booster injections spaced 6 months apart, totaling 11 injections over 3 years. There are three groups one receiving placebo 0.9% normal saline, one receiving GLSI-100 immunotherapy in HLA-A*02 positive subjects, and an open-label arm for non-HLA-A*02 positive subjects receiving GLSI-100 under the same schedule. During the study, participants undergo regular monitoring and assessments including invasive disease-free survival, distant disease-free survival, overall survival, and quality of life questionnaires at baseline and up to 36 months. Researchers track safety and treatment effects over a median 4-year follow-up. The study continues until December 2031, aiming to provide comprehensive data on long-term outcomes and quality of life for participants receiving these treatments.

Squamous cell carcinoma of the anus is a rare but increasingly common cancer, often linked to human papillomavirus HPV. For early-stage tumors, combined radiotherapy and chemotherapy with 5FU and mitomycin-C provide good outcomes, but advanced tumors have a poor prognosis with a high relapse rate. Researchers are studying a new approach combining induction chemotherapy with docetaxel, cisplatin, and 5FU mDCF followed by standard chemoradiotherapy to improve treatment results for locally advanced anal cancer T3-4 or N1. This is a randomized phase 3 trial comparing this new strategy to the current standard treatment. The study includes two groups one receives the usual chemoradiotherapy, which involves 33 radiotherapy sessions over 6.5 weeks combined with mitomycin-C and capecitabine chemotherapy taken on radiotherapy days. The other group starts with 4 cycles of mDCF chemotherapy given every two weeks before receiving the same chemoradiotherapy as the control group. Radiotherapy uses intensity-modulated external irradiation with a targeted boost to the tumor and involved lymph nodes. Participants will be followed after treatment with check-ups at 8 weeks, then every 4 months for two years, and every 6 months in the third year. Follow-up includes clinical exams and imaging scans CT and MRI. The main measure of success is disease-related event-free survival two years after treatment. Other outcomes include overall survival, colostomy-free survival, treatment side effects, tumor response, and quality of life. The total study duration for each participant may extend over several years including this follow-up period.

Researchers are evaluating the use of rifabutin compared to rifampicin for treating staphylococcal prosthetic joint infections PJIs managed with a strategy called DAIR debridement, antibiotics, and implant retention. Rifampicin is a key antibiotic for these infections but has notable risks of drug interactions and liver problems. The study investigates whether rifabutin can be a safe and effective alternative with fewer side effects. This is a Phase 3, randomized, open-label trial aimed at demonstrating that rifabutin is not less effective than rifampicin for this treatment. Participants will be randomly assigned to one of two groups. One group will receive rifampicin combined with another antibiotic for 12 weeks according to current recommendations. The other group will receive rifabutin with a companion antibiotic, also for 12 weeks. Rifabutin is given as two 150 mg tablets once daily, while rifampicin dosing is based on weight 600 mg to 1200 mg daily. Both treatments are oral and part of combination antibiotic therapy during the DAIR procedure. During the study, researchers will monitor participants for treatment failure at one year, adverse events related to the antibiotics, adherence to the medication regimen, and completion of the 12-week treatment course. Quality of life and functional outcomes will be assessed using questionnaires over an average follow-up of 24 months. Safety monitoring includes checking for serious adverse events during and after treatment. Participants progress will be tracked through regular evaluations throughout the study period.

Researchers are studying women with non-metastatic breast cancer who are undergoing adjuvant hormone therapy. The trial aims to compare the effects of adding a therapeutic education program combined with nursing phone follow-up to the usual care on managing side effects during the first year of treatment. This supportive care approach focuses on improving patients quality of life and reducing adverse effects related to hormone therapy. Participants in the experimental group will receive conventional oncology follow-up plus an initial educational assessment day around the time they start hormone therapy. A nurse will work with each patient to set personalized goals and select appropriate workshops in an outpatient educational program. The control group will receive only the standard oncology follow-up without additional education or nursing support. During the study, participants will be monitored for adverse events, quality of life, sleep quality, medication use, treatment adherence, confidence in using hormone therapy, knowledge about their disease and treatment, satisfaction with care, and economic impacts. These measures will be assessed at baseline, 2 months, 6 months, and 12 months. The programs acceptability and patients use of non-drug management methods will also be evaluated over one year.

Peripheral T-cell lymphoma PTCL includes several mature T-cell lymphoma subtypes, such as angioimmunoblastic T-cell lymphoma and others, which together make up about 20 to 25% of mature T- and NKT-cell lymphomas. These lymphomas generally have a poor prognosis compared to B-cell lymphomas, with a 10-year survival rate around 30% except for ALK-positive anaplastic large cell lymphoma. There is no clear consensus on the best first-line treatment for most PTCL types, and the role of autologous stem cell transplantation ASCT as consolidation after chemotherapy response remains debated. Patients in this study receive chemotherapy every three weeks for six cycles, with regimens chosen by the local investigator based on standard practices. Chemotherapy options include CHOP, CHOEP, or BV-CHP for ALCL lymphoma. Those achieving a complete response after chemotherapy may be randomized to receive ASCT consolidation with a high-dose therapy conditioning regimen called BEAM, which lasts 2 to 3 months. Evaluations with PET-CT or CT scans occur after four cycles, post-induction, and again 8 to 12 weeks after post-induction. Participants will undergo multiple scans and assessments to monitor disease status and treatment effects, including metabolic tumor volume and response evaluation by PET-CT. The main outcome measured is progression-free survival after ASCT. Secondary outcomes include overall survival, response rates, duration of response, time to next treatment, quality of life, and cost-effectiveness. The study follows patients for at least two years after randomization or until key events such as progression or relapse occur.

Researchers are investigating osteolytic bone metastases and myeloma bone lesions that cause fractures in long bones and vertebrae, leading to limited mobility, surgery, and spinal cord compression. These complications greatly affect quality of life and have significant medical and economic consequences. The study aims to improve fracture risk assessment, which is currently based on simple X-rays and scores like Mirels and SINS, by using quantitative CT scans and advanced numerical simulation techniques to better evaluate the mechanical strength of bones affected by tumors. This observational study enrolls adult patients with bone metastases or myeloma lesions in the upper femur or vertebrae from cancers such as breast, lung, kidney, thyroid, or bladder. Participants undergo quantitative CT scans of the affected bone areas. The mechanical strength of the tumor-affected bone is assessed using finite element analysis FEA, a numerical simulation method that accounts for bone and tumor properties. This approach is compared to traditional fracture risk scores to determine its added value. Participants provide informed consent and have a CT scan performed within 30 days before or 20 days after study inclusion, as part of their usual care. Researchers collect data on bone and tumor characteristics to predict fracture risk and improve management strategies. The primary outcome is the mechanical strength measurement of the tumor-affected femur or vertebrae over 24 months. The study supports better prevention of fractures in patients with bone metastases while coordinating with their oncology treatment.